System and method for treating abnormal tissue in an organ having a layered tissue structure

Abstract

A method, and system, are provided treating a tissue site of a tissue structure that has at least a first and a second tissue plane. An energy delivery device is provided. A barrier is created between the first and second tissue planes. At least a portion of an energy delivery device is positioned at the tissue site. Sufficient energy is delivered from the energy delivery device to create cell necrosis of at least a portion of the first tissue plane.

What is claimed is:  
     
         1 . A method of treating a tissue site of a tissue structure that has at least a first and a second tissue plane, comprising: 
 providing an energy delivery device;    creating a barrier between the first and second tissue planes;    positioning at least a portion of an energy delivery device at the tissue site; and    delivering sufficient energy from the energy delivery device to create cell necrosis of at least a portion of the first tissue plane.    
     
     
         2 . The method of  claim 1 , wherein a barrier material is injected into a space between the first and second tissue planes.  
     
     
         3 . The method of  claim 2 , wherein the barrier material attenuates transmission of energy delivered by the energy delivery device.  
     
     
         4 . The method of  claim 3 , wherein the barrier material is a fluid.  
     
     
         5 . The method of  claim 4 , wherein the fluid is a liquid fluid.  
     
     
         6 . The method of  claim 3 , wherein the fluid is a gaseous fluid.  
     
     
         7 . The method of  claim 3 , wherein the barrier material includes a connective tissue weakening agent for improving the separation of the tissue layers.  
     
     
         8 . The method of  claim 7 , wherein the connective tissue weakening agent includes hyaluronidase.  
     
     
         9 . The method of  claim 4 , wherein the fluid is thermally insulating.  
     
     
         10 . The method of  claim 4 , wherein the fluid is electrically insulating.  
     
     
         11 . The method of  claim 4 , wherein the fluid is electrically conducting.  
     
     
         12 . The method of  claim 4 , wherein the fluid-tissue interface is ultrasonically reflecting or ultrasonically absorbing.  
     
     
         13 . The method of  claim 4 , wherein the fluid is optically reflecting or absorbing.  
     
     
         14 . The method of  claim 1 , further comprising: 
 providing an injection catheter for introducing the having a lumen therethrough, a distal region, an injection orifice disposed in the distal region and in fluid communication with the lumen.    
     
     
         15 . The method of  claim 14 , further comprising: 
 injecting the barrier material in one or more radially spaced injection in a region of the tissue site.    
     
     
         16 . The method of  claim 15 , wherein a plurality of radially spaced injections are made in the region of the tissue site, the plurality of radially spaced injections being spaced between about 0.5 and 2 centimeters.  
     
     
         17 . The method of  claim 14 , wherein about 1 and 10 cubic centimeters of barrier material are injected at the tissue site.  
     
     
         18 . The method of  claim 14 , wherein at least four radially spaced injections are made at the tissue site.  
     
     
         19 . The method of  claim 2 , wherein the barrier material is colored with methylene blue or food coloring.  
     
     
         20 . The method of  claim 2 , wherein the first tissue plane is the mucosa, the second tissue plane is muscle and wherein a third tissue plane is a submucosa that is located between the mucosa and muscle planes.  
     
     
         21 . The method of  claim 20 , wherein the mucosa and submucosa tissue planes are separated from the muscle plane.  
     
     
         22 . The method of  claim 21 , wherein the mucosa plane is separated from the submucosa plane.  
     
     
         23 . The method of  claim 2 , wherein the tissue site is at a gastrointestinal or genitourinary organ.  
     
     
         24 . The method of  claim 2 , wherein the tissue site is any tissue site with multiple tissue planes.  
     
     
         25 . The method of  claim 1 , wherein the energy delivery device is coupled to an expandable member.  
     
     
         26 . The method of  claim 25 , further comprising: 
 expanding the expandable member.    
     
     
         27 . The method of  claim 1 , wherein the first tissue plane is a mucosal layer of the esophagus.  
     
     
         28 . The method of  claim 27 , wherein the expandable member is expandable sufficiently to cause at least a portion of the energy delivery device to be in contact with the esophagus mucosal layer.  
     
     
         29 . The method of  claim 2 , further comprising: 
 identifying an existence of abnormal tissue in the mucosal layer.    
     
     
         30 . The method of  claim 29 , wherein the abnormal tissue is visually identified.  
     
     
         31 . The method of  claim 1 , wherein the energy is delivered from an RF source.  
     
     
         32 . The method of  claim 1 , wherein the energy is delivered from a microwave source.  
     
     
         33 . The method of  claim 1 , wherein the energy is delivered from an optical source.  
     
     
         34 . The method of  claim 1 , wherein the energy is delivered from an ultraviolet light source.  
     
     
         35 . The method of  claim 1 , wherein the energy is delivered from a thermal source.  
     
     
         36 . The method of  claim 1 , wherein the energy is delivered from a resistive heating source..  
     
     
         37 . The method of  claim 1 , wherein the abnormal tissue is selected from Barrett's epithelium, variants of Barrett's epithelium, dysplastic tissue and malignant tissue.  
     
     
         38 . A method of treating an esophagus tissue site with at least a first and a second tissue plane, comprising: 
 introducing an energy delivery device through an oral cavity and into the esophagus;    positioning at least a portion of an energy delivery device at the esophagus tissue site; and    creating a barrier between the first and second tissue planes;    positioning at least a portion of an energy delivery device at the esophagus tissue site; and    delivering energy from the energy delivery device at different times to create cell necrosis of at least a portion of the first tissue plane.    
     
     
         39 . The method of  claim 38 , wherein a barrier material is injected into a space between the first and second tissue planes.  
     
     
         40 . The method of  claim 39 , wherein the energy delivery device is coupled to an expandable member.  
     
     
         41 . The method of  claim 40 , further comprising: 
 expanding the expandable member.    
     
     
         42 . The method of  claim 41 , further comprising: 
 viewing the cell necrosis.    
     
     
         43 . The method of  claim 41 , wherein the first plane of the tissue site is a mucosal tissue of the esophagus.  
     
     
         44 . The method of  claim 43 , wherein the first plane of the tissue site is a mucosal tissue and a sub-mucosal tissue of the esophagus.  
     
     
         45 . The method of  claim 43 , wherein the expandable member is expandable sufficiently to cause at least a portion of the energy delivery device to be in contact with the esophagus mucosal layer.  
     
     
         46 . The method of  claim 43 , further comprising: 
 identifying an existence of abnormal tissue in the mucosal layer.    
     
     
         47 . The method of  claim 46 , wherein the abnormal tissue is visually identified.  
     
     
         48 . The method of  claim 38 , wherein the energy is delivered from an RF source.  
     
     
         49 . The method of  claim 38 , wherein the energy is delivered from a microwave source.  
     
     
         50 . The method of  claim 38 , wherein the energy is delivered from an optical source.  
     
     
         51 . The method of  claim 38 , wherein the energy is delivered from an ultraviolet light source.  
     
     
         52 . The method of  claim 38 , wherein the energy is delivered from a thermal source.  
     
     
         53 . The method of  claim 38 , wherein the energy is delivered from a resistive heating source.  
     
     
         54 . The method of  claim 38 , wherein the abnormal tissue is selected from Barrett's epithelium, variants of Barrett's epithelium, dysplastic tissue and malignant tissue.  
     
     
         55 . A method of treating an esophagus tissue site with at least a first and a second tissue plane, comprising: 
 introducing an energy delivery device through an oral cavity and into the esophagus;    creating a barrier between the first and second tissue planes positioning at least a portion of an energy delivery device at the esophagus tissue site; and    delivering energy from the energy delivery device to create a controlled cell necrosis of at least a portion of the first tissue plane while minimizing permanent damage to esophageal muscularis tissue.    
     
     
         56 . The method of  claim 55 , wherein a barrier material is injected into a space between the first and second tissue planes.  
     
     
         57 . The method of  claim 55 , wherein the energy delivery device includes an expandable member.  
     
     
         58 . The method of  claim 57 , further comprising: 
 expanding the expandable member.    
     
     
         59 . The method of  claim 55 , further comprising: 
 viewing the cell necrosis.    
     
     
         60 . The method of  claim 55 , wherein the tissue site is a mucosal tissue of the esophagus.  
     
     
         61 . The method of  claim 55 , wherein the tissue site is a mucosal tissue and a sub-mucosal tissue of the esophagus.  
     
     
         62 . The method of  claim 57 , wherein the expandable member is expandable sufficiently to cause at least a portion of the energy delivery device to be in contact with the esophagus mucosal layer.  
     
     
         63 . The method of  claim 60 , further comprising: 
 identifying an existence of abnormal tissue in the mucosal layer.    
     
     
         64 . The method of  claim 56 , wherein the abnormal tissue is visually identified.  
     
     
         65 . The method of  claim 55 , wherein the energy is delivered from an RF source.  
     
     
         66 . The method of  claim 55 , wherein the energy is delivered from a microwave source.  
     
     
         67 . The method of  claim 55 , wherein the energy is delivered from an optical source.  
     
     
         68 . The method of  claim 55 , wherein the energy is delivered from an ultraviolet light source.  
     
     
         69 . The method of  claim 55 , wherein the energy is delivered from a thermal source.  
     
     
         70 . The method of  claim 55 , wherein the energy is delivered from a resistive heating source.  
     
     
         71 . The method of  claim 55 , wherein the abnormal tissue is selected from Barrett's epithelium, variants of Barrett's epithelium, dysplastic tissue and malignant tissue.  
     
     
         72 . A method of treating an esophagus tissue site with at least a first and a second tissue plane, comprising: 
 introducing an energy delivery apparatus through an oral cavity and into the esophagus, the energy delivery apparatus including a plurality of RF electrodes, a width of each RF electrode and a spacing between adjacent RF electrodes selected to provide a selectable ablation of an esophagus mucosal tissue;    creating a barrier between the first and second tissue planes;    positioning at least a portion of an energy delivery device at the esophagus tissue site; and    delivering energy from the energy delivery device to create a controlled cell necrosis of at least a portion of the first tissue plane while minimizing permanent damage to a muscularis tissue.    
     
     
         73 . The method of  claim 72 , wherein a barrier material is injected into a space between the first and second tissue planes.  
     
     
         74 . The method of  claim 72 , wherein the plurality of RF electrodes are arranged in a pattern.  
     
     
         75 . The method of  claim 72 , where at least a portion of the plurality of RF electrodes are bi-polar RF electrodes.  
     
     
         76 . The method of  claim 72 , wherein a width of each RF electrode is no more than 3 mm.  
     
     
         77 . The device of  claim 72 , wherein a width of each RF electrode is no more than 2 mm.  
     
     
         78 . The device of  claim 72 , wherein a width of each RF electrode is no more than 1 mm.  
     
     
         79 . The device of  claim 72 , wherein a width of each RF electrode is no more than 0.5 mm.  
     
     
         80 . The device of  claim 72 , wherein a spacing between adjacent RF electrodes is no more than 2 mm.  
     
     
         81 . The device of  claim 72 , wherein a spacing between adjacent RF electrodes is no more than 1 mm.  
     
     
         82 . The device of  claim 72 , wherein a spacing between adjacent RF electrodes is no more than 0.5 mm.  
     
     
         83 . The device of  claim 72 , wherein the plurality of electrodes are arranged in segments.  
     
     
         84 . The device of  claim 83 , wherein at least a portion of the segments are multiplexed.  
     
     
         85 . The device of  claim 84 , wherein an RF electrode between adjacent segments is shared by each of adjacent segments when multiplexed.  
     
     
         86 . An apparatus for separating tissue planes at a tissue site, comprising, 
 an instrument body having an elongated shaft portion sized and constructed for insertion through an endoscope and into the interior of the tissue site of a patient;    a separation mechanism at a distal end of the elongated shaft that is attachable to at least a portion of the tissue site, the separation mechanism providing a separation of at least one tissue plane from a second tissue plane; and    an injection device coupled to the instrument body.    
     
     
         87 . The apparatus of  claim 86 , wherein the separation mechanism includes two opposing jaws.  
     
     
         88 . The apparatus of  claim 87 , wherein at least one of the two opposing jaws is grooved and spaced to permit passage of at least a portion of the injection device.  
     
     
         89 . The apparatus of  claim 86 , wherein the separation mechanism is a ring or u-shaped member.  
     
     
         90 . The apparatus of  claim 89 , wherein the ring or u-shaped member is adapted to allow passage of at least a portion of the injection device.  
     
     
         91 . The apparatus of  claim 86 , wherein at least a portion of the instrument body is hollow and the injection device includes a recessed needle that can be extruded for injection.  
     
     
         92 . A system for creating cell necrosis from a tissue site at a human esophagus, comprising: 
 a cell necrosis device;    an injection catheter for injecting a barrier material to separate esophageal tissue layers by flowing between tissue layers or expanding one of the tissue layers, the injection catheter having a lumen therethrough, a proximal region, a proximal port, a distal region, and an injection orifice at a distal region and in fluid communication with the lumen; and    a fluid supply coupled to the injection catheter proximal port for forcing the barrier fluid through the injection catheter distal orifice.    
     
     
         93 . The system of  claim 92 , wherein the injection catheter has a stop disposed in the catheter distal region for limiting penetration of the catheter into the esophageal tissue.  
     
     
         94 . The system of  claim 93 , further comprising an endoscope adapted to admit the injection catheter therethrough.  
     
     
         95 . The system of claim,  92  wherein the energy therapy further includes the use of a drug sensitizer.  
     
     
         96 . The method of  claim 1 , further comprising: 
 viewing the cell necrosis.